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NCT03112603 · OUTCOME

Overall Survival (OS)

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)

What was measured

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

Analysis population: FAS

Groups in this outcome

Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ruxolitinib165
Best Available Therapy164

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RuxolitinibNANot reportedNANAThe median and upper and lower limits of the confidence interval were not estimable because too few participants died.
Best Available TherapyNANot reported41.0NAThe median and upper limit of the confidence interval were not estimable because too few participants died.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.544
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.331
    estimate Comment
    The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.2396
    p Value Comment
    The p-value was derived from a 1-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.851
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.544
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.331
    estimate Comment
    The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.2396
    p Value Comment
    The p-value was derived from a 1-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.851
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median and upper and lower limits of the confidence interval were not estimable because too few participants died.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median and upper limit of the confidence interval were not estimable because too few participants died.
        group Id
        OG001
        lower Limit
        41.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    OG000
    title
    Ruxolitinib
  2. description
    Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
    id
    OG001
    title
    Best Available Therapy
param Type
MEDIAN
population Description
FAS
reporting Status
POSTED
time Frame
from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice